Analytical Development Manager

Job Detail

Job-ID 332284

Job-Beschreibung

Analytical Development ManagerWork Location: Allschwil, SwitzerlandAbout the Role:A pharmaceutical business is seeking a dedicated and experienced Manager in Analytical Development-Quality Control (AD/QC). This role is pivotal in ensuring that Drug Substance (DS) and Drug Product (DP) meet the highest quality standards and comply with GMP and regulatory guidelines.Key Responsibilities:Team Management: Lead and manage a team of up to 3 direct reports.Project Oversight: Handle a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late-stage projects (typically phase 3 and commercial).Laboratory Organization: Oversee laboratory activities, ensuring adherence to Guidelines and SOPs.Method Development: Develop, optimize, and implement analytical methods for various determinations, including purity, stability, and cleaning verification/validation.Project Representation: Represent AD/QC in technical project team and CMC team meetings.Analytical Studies: Conduct release, retest, stability studies, transfer, and validation analyses.Documentation: Ensure proper documentation of all analytical activities according to Good Documentation Practices.Data Review: Review, interpret, and document analytical data from various studies.Protocol Writing: Write and review analytical protocols and reports, and establish specifications.Equipment Maintenance: Ensure adequate maintenance and operation of analytical equipment according to GMP.Document Drafting: Draft and review CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs, and FRMs.Qualification Plans: Organize GMP-(re)qualification and validation of analytical equipment with external companies.Training: Ensure initial and continuing training of AD/QC personnel and adapt training according to business needs.Laboratory Cleanliness: Maintain cleanliness of laboratory and workspace.Project Execution: Independently design and execute projects or experiments with hands-on involvement.Scientific Review: Independently review scientific work in project-related activities.Material Availability: Ensure availability of adequate lab materials and justify acquisition of new materials or equipment.External Contacts: Act as a contact for 3rd parties, such as CMOs and CROs, for defined analytical tasks.Novel Techniques: Independently evaluate and develop novel analytical techniques and instrumentation.Workload Management: Leverage workload of project members to ensure timelines and budget are met.Regulatory Submissions: Establish source documents for IND, IMPD, and NDA/MA submissions, respond to agency questions, and interact with Health Authorities.Troubleshooting: Design and lead laboratory work to support product or process troubleshooting, special investigations, deviations, change requests, CAPA, product complaints, and other analytical tasks.Timeline Management: Set and accomplish product development timelines in collaboration with formulation scientists.GMP Laboratory Management: Manage the GMP laboratory and employees.Analytical Expertise: Provide analytical expertise for defined drug substances and/or drug products.Communication: Summarize, defend, and communicate results and product quality issues to management.Outsourcing Management: Manage the outsourcing of analytical activities to CROs/CMOs, including supplier selection input.Technology Transfer: Participate in technology transfer between laboratories, both internal and external.Qualifications:

Proven experience in pharmaceutical analytical development and quality control.
Strong leadership and project management skills.
In-depth knowledge of GMP and regulatory guidelines.
Excellent communication and documentation skills. Ability to work independently and as part of a team.

Apply today to be part of a dynamic and innovative team!